Bacteria count culture medium for limit test of microbe in medication of quinolone category, and application

Abstract

This invention discloses a bacteria-counting culture medium for microbial limit test of quinolone drugs. The culture medium is composed of multivalent cationic metal salt and nutrient agar culture medium at a ratio of 0.001-0.05 mol / L. The culture medium can be used for microbial limit test of sterile orally taken or external use quinolone raw material, oral injection and external use preparations, and is effective and simple.

Description

technical field [0001] The invention relates to a quinolone drug microorganism limit test bacteria count culture medium and application thereof, belonging to the field of microbial culture medium engineering. Background technique [0002] Microbial contamination of pharmaceutical products is one of the potential unsafe factors. In order to ensure the safety of clinical application, the pharmacopoeias of various countries not only require sterility testing for injectable drugs, but also have clear quality control indicators for microbial contamination of oral preparations. [0003] Pharmaceutical products are all processed through various production steps, which often make the microorganisms that may be contaminated in a damaged, dormant or sub-lethal state, and many drugs themselves are also unfavorable to the growth of microorganisms, or have killing or lethal effects, which exacerbates this problem. a state. However, once damaged, dormant or sub-lethal microorganisms ente...

AI Technical Summary

Problems solved by technology

The only way to solve this problem is to increase the amount of flushing, but there are many defects in relying on this single method. First, after the mechanical flushing reaches a certain level, the basic adsorption amount of the drug on the filter membrane and the flushing reach a balance. , making it difficult to completely remove it by increasing the amount of flushing; second, long-term and large-volume flushing is not allowed in the sterility test, which may cause changes in the pore size of the filter membrane and invalidate the test results, or may be caused by long-term liquid flow. The shear force caused the death of contaminating microorganisms, and missed detection